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Evaluating Primary Care Behavioral Counseling Interventions: An Evidence-based Approach


By Evelyn P. Whitlock, M.D., M.P.H.a, C. Tracy Orleans, Ph.D.b, Nola Pender, R.N., Ph.D., FAANc, Janet Allan, R.N., Ph.D., C.S.d

Address correspondence to: Evelyn P. Whitlock, M.D., M.P.H.; Kaiser Permanente/CHR; 3800 North Interstate Avenue; Portland, Oregon 97227-1098; E-mail: Evelyn.whitlock@kpchr.org

This article originally appeared in Am J Prev Med 2002;22(4):267-84. Select for copyright and source information.


Rationale for Behavioral Counseling Interventions in Clinical Care
Objectives and Scope of Behavioral Counseling Interventions
   Theories and Models of Behavior Change
   The Clinician-Patient Relationship
The Potential Impact of Health Behavior-Change Programs in Clinical Care
Practical Approaches to Overcome Barriers to Behavioral and Counseling Interventions
Evidence-Based Methods for Evaluating Behavioral Counseling Interventions
   Analytic Framework 1: Does Changing Individual Health Behavior Improve Health Outcomes?
   Analytic Framework 2: Can Interventions in the Clinical Setting Influence People to Change Their Behavior?
   Aligning Evidence With Usefulness in Clinical Settings
The Five A's Organizational Construct for Clinical Counseling
   Rationale and Strategies for Implementing the Five A's
Author Affiliations
Copyright and Source Information


Risky behaviors are a leading cause of preventable morbidity and mortality, yet behavioral counseling interventions to address them are underutilized in health care settings. Research on such interventions has grown steadily, but the systematic review of this research is complicated by wide variations in the organization, content, and delivery of behavioral interventions and the lack of a consistent language and framework to describe these differences. The Counseling and Behavioral Interventions Work Group of the U.S. Preventive Services Task Force (USPSTF) was convened to address adapting existing USPSTF methods to issues and challenges raised by behavioral counseling intervention topical reviews.

The systematic review of behavioral counseling interventions seeks to establish whether such interventions addressing individual behaviors improve health outcomes. Few studies directly address this question, so evidence addressing whether changing individual behavior improves health outcomes and whether behavioral counseling interventions in clinical settings help people change those behaviors must be linked. To illustrate this process, we present two separate analytic frameworks derived from screening topic tools that we developed to guide USPSTF behavioral topic reviews.

No simple empirically validated model captures the broad range of intervention components across risk behaviors, but the Five A's construct—assess, advise, agree, assist, and arrange—adapted from tobacco cessation interventions in clinical care provides a workable framework to report behavioral counseling intervention review findings. We illustrate the use of this framework with general findings from recent behavioral counseling intervention studies.

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In 1998, the Agency for Healthcare Research and Quality (AHRQ) reconvened the U.S. Preventive Services Task Force (USPSTF) to update its recommendations for clinical preventive services. This Task Force represents primary care disciplines (nursing, pediatrics, family practice, internal medicine, and obstetrics/gynecology), preventive medicine, and behavioral medicine. Two evidence-based practice centers (EPCs)—Oregon Health & Science University and RTI/University of North Carolina—were contracted to prepare systematic evidence reviews that the USPSTF uses in developing its recommendations for preventive care.

Although the USPSTF evidence-based methods are widely applicable throughout medicine, to date they have been used primarily to assess services such as preventive screening, rather than those requiring behavioral counseling.1,2 The current USPSTF recognized a two-fold need:

  1. To expand its evidence-based approach to better assess behavioral counseling interventions.
  2. To formulate practical communication strategies for describing services that are effective in changing behavior.

The Counseling and Behavioral Interventions Work Group of the USPSTF adapted the USPSTF generic screening analytic framework, which guides systematic reviews, to address behavioral topics more specifically, and it has promoted a consistent organizational construct for describing behavioral counseling interventions. Clinicians are referred to current products of the USPSTF (1-800-358-9295) for systematic evidence reviews of specific behavioral counseling topics and related USPSTF evidence-based recommendations and clinical considerations beyond the scope of this paper.

This paper has three purposes:

  1. To promote a broader appreciation of the importance of behavioral counseling interventions in clinical care and the context for their delivery.
  2. To describe the generic analytic frameworks developed to guide the systematic review of behavioral counseling topics for the current USPSTF.
  3. To detail the practical organizational construct (the Five A's) adopted by the USPSTF to describe intervention research more consistently in order to foster its application in clinical settings.

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Healthy People 20103 sets two major goals for the United States:

  1. To increase quality and years of healthy life.
  2. To eliminate health disparities among different segments of the population.

The next decade offers unprecedented opportunities for health care systems and providers to address these goals by promoting healthy lifestyles among the diverse populations they serve and by adopting policies that will institutionalize preventive services.

Changing the health behaviors of Americans has the greatest potential of any current approach for decreasing morbidity and mortality and for improving the quality of life across diverse populations.4 In their landmark paper, McGinnis and Foege5 linked 50 percent of the mortality in the United States from the 10 leading causes of death to lifestyle-related behaviors such as tobacco use, poor dietary habits and inactivity, alcohol misuse, illicit drug use, and risky sexual practices. These behaviors remain problematic in today's society despite having been previously targeted for improvement.6 Thus, the U.S. Department of Health and Human Services has designated five lifestyle factors as Healthy People 20103 health indicators by which to track progress in improving the health of the nation over the next decade (Table 1). Improving health behaviors is an important approach to health disparities, because those who are economically and/or socially disadvantaged, including those in low-income ethnic/racial minority groups, disproportionately bear the prevalence of risky health behaviors and the burden of preventable morbidity and mortality.7

The unabated impact of health-damaging behaviors among Americans makes it imperative that health care providers and health care systems seriously consider these behavioral issues and accept the challenge of routinely providing quality behavioral counseling interventions where proven effective. The 1996 edition of the Guide to Clinical Preventive Services by the USPSTF concluded: "Effective interventions that address personal health practices ... [for] ... primary prevention ... hold greater promise for improving overall health than many secondary preventive measures, such as routine screening for early disease. Therefore, clinician counseling that leads to improved personal health practices may be more valuable than conventional clinical activities, such as diagnostic testing."1

Nevertheless, rates of behavioral counseling intervention by pediatricians, nurse practitioners, obstetrician-gynecologists, internists, and family physicians for the priority behaviors discussed above still fall far below national targets.3,8,9 In fact, gaps in the delivery of clinical preventive services are greater for behavioral counseling than for screening or chemoprevention.10 This stems in part from the relative paucity of good research evidence to support the behavioral counseling intervention recommendations in the 1996 Guide to Clinical Preventive Services.1

The quality and quantity of good research evidence for the effectiveness of behavioral counseling interventions are increasing. Brief interventions integrated into routine primary care can effectively address the most common and important risk behaviors.11-22 The strongest evidence for the efficacy of primary care behavior-change interventions comes from tobacco cessation research11,12,14,15,19 and, to a lesser extent, problem drinking.11,16-19,21,22 Accumulating evidence also shows the effectiveness of similar interventions for other behaviors.11,19,20

These interventions often provide more than brief clinician advice. Effective interventions typically involve behavioral counseling techniques and use of other resources to assist patients in undertaking advised behavior changes.12,19 For example, intervention adjuncts to brief clinician advice may involve a broader set of health care team members (e.g., nurses, other office staff, health educators, and pharmacists), a number of complementary communication channels (e.g., telephone counseling,22,23 video or computer-assisted interventions,24-26 self-help guides,27 and tailored mailings28), and multiple contacts with the patient.12,14,19,29

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Rationale for Behavioral Counseling Interventions in Clinical Care

Health care providers and their staff play a unique and important role in motivating and assisting patients' healthy behavior changes. Patients report that primary care clinicians are expected sources of preventive health information and recommendations for patients.30 For instance, in a recent survey, the vast majority (92 percent to 98 percent) of adult members of health maintenance organizations (HMO) indicated that they expected advice and help from the health care system in key behaviors, such as diet, exercise, and substance use.31 Similarly, health care providers generally accept32 and value their role in motivating health promotion and disease prevention.33,34

Health care systems are natural settings for interventions to improve health behaviors for many individuals because repeated contacts typically occur over a number of years. Interventions to help patients change unhealthy behaviors, like treatments for patients with chronic disease, often require repetition for modest effects over time. Continuity of care offers opportunities to sustain individual motivation, assess progress, provide feedback, and adjust behavior change plans.35

In fact, most clinicians have multiple opportunities to intervene with patients on matters related to health behavior change: patients younger than 15 years average 2.4 visits per person annually to office-based physicians, and those 15 years of age and older average 1.6 to 6.3 visits per year, with visit frequency increasing with age.36 Moreover, 93 percent of children and youth and 84 percent of adults 18 years of age and older have a specific source of ongoing health care.3 Not surprisingly, people with a usual source of health care are more likely than those without to receive a variety of clinical preventive services.3

The health care setting is not the only setting for approaches to support healthy behaviors. The Guide to Community Preventive Services features evidence-based recommendations from the Task Force on Community Preventive Services for population-based interventions. Those recommendations include policy or environmental changes or individual and group interventions outside the clinical setting intended to change risky behaviors; reduce specific diseases, injuries and impairments; and address environmental and ecosystem challenges.37 These preventive policies and approaches complement the individually focused interventions that the USPSTF addresses.

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Objectives and Scope of Behavioral Counseling Interventions

Behavioral counseling interventions in clinical care are those activities delivered by primary care clinicians and related health care staff to assist patients in adopting, changing, or maintaining behaviors proven to affect health outcomes and health status. Common health-promoting behaviors include smoking cessation, healthy diet, regular physical activity, appropriate alcohol use, and responsible use of contraceptives.

Behavioral counseling interventions occur all or in part during routine primary care and may involve both visit-based and outside intervention components. For instance, assessment of behavioral health risks may occur at the time of enrollment in a health plan or at the time of a clinical visit. Behavioral counseling may take place in routine primary care visits and/or through telephone contacts or personalized mailings of self-help guides or materials. Referral to more intensive clinics in the community also may be included. While the USPSTF primarily evaluates interventions that involve clinicians as part of routine primary care, USPSTF liaisons assigned to a particular behavioral topic define the scope of clinical intervention approaches reviewed for any given topic, such as problem drinking or physical activity.

Behavioral counseling interventions differ from screening interventions in several important ways that affect the ease and likelihood of their being delivered. Behavioral counseling interventions address complex behaviors that are integral to daily living; they vary in intensity and scope from patient to patient; they require repeated action by both patient and clinicians, modified over time, to achieve health improvement; and they are strongly influenced by multiple contexts (family, peers, worksite, school, and community).

Further, "counseling" is a broadly used but imprecise term that covers a wide array of preventive and therapeutic activities, from mental health or marital therapy to the provision of health education and behavior change support. Thus, we have chosen to use the term "behavioral counseling interventions" to describe the range of personal counseling and related behavior-change interventions that are effectively employed in primary care to help patients change health-related behaviors. As with its use in other contexts, "counseling" here denotes a cooperative mode of work demanding active participation from both patient and clinician that aims to facilitate the patient's independent initiative and ability to cope.38 Engaging patients actively in the self-management practices needed to change and maintain healthy behaviors is a central component of effective behavioral counseling interventions.

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Theories and Models of Behavior Change

Behavior change theories and models from the social and behavioral sciences explain the biological, cognitive, behavioral, and psychosocial/environmental determinants of health-related behaviors. Thus, they also define interventions to produce changes in knowledge, attitudes, motivations, self-confidence, skills, and social supports required for behavior change and maintenance.39 The application of relevant theoretical models to behavioral counseling interventions is an important contribution to strengthening health research in this area.40

A literature review of 1,174 articles evaluating health behavior, education, and promotion interventions published between 1992 and 1994 found that 44.8 percent of these were explicitly theory based.41 Six theories and models addressing determinants of health-behavior change at the intrapersonal, interpersonal, and environmental levels (Table 2) and two cross-theoretical key constructs/theories were most commonly cited in this research. Promising, if not substantial, empirical evidence supports the validity of all eight theories in predicting or changing health behavior.41 In addition to those listed in Table 2, self-efficacy and social network/support were the other two most commonly cited constructs in the current literature. Self-efficacy is an individual's level of confidence in his or her own skills and persistence to accomplish a desired goal and predicts future behavior across a wide variety of lifestyle risk factors.42 Social networks are a person-centered web of social relationships.43 These relationships provide social support that can assist the individual through "stress-buffering" and other mechanisms.43

These theories focus on diverse, interacting levels of influence on an individual's behavior. On the intrapersonal level, multiple internal factors influence an individual's behavioral choices and actions, and there is considerable variability in these factors among individuals with the same objective health behavior. For example, in the stages-of-change/transtheoretical model (Table 2), behavioral change is thought of as an ongoing process with multiple stages that often includes relapse and recycling into renewed efforts to change.44 On the interpersonal level, individual behavioral choices occur in a context that includes the influence of social and environmental conditions in the family and larger community.41,45

Behavioral influences operate within a broadly conceptualized ecological paradigm emphasizing that a dynamic interaction between functional levels—intrapersonal, interpersonal, and the physical environment—continues over an individual's lifetime, and that age, gender, race, ethnicity, and socioeconomic status play a critical role in health and health decisions.40,46 Similarly, the Institute of Medicine47 recently concluded that "interventions must recognize that people live in social, political, and economic systems that shape behaviors and access to the resources they need to maintain good health."

According to another recent Institute of Medicine report,40 there is an emerging consensus that social and behavioral research and intervention efforts should be based on this broader ecologic model that incorporates and relates focused approaches across levels. Thus, omission of any key dimension in research or practice reduces the likelihood of successfully addressing problem behaviors, such as smoking.48 More than a brief overview of theories and models is beyond the scope of this paper and can be found elsewhere.39-46

Although these theoretical constructs are unfamiliar to many clinicians, they can help practitioners conceptualize the complex context in which individual behavioral choice occurs and the variability among patients in their receptivity to behavioral counseling interventions at any one time. These insights can clarify barriers, opportunities, and the relative intensity of intervention needed to successfully address behavior change for a given individual.

Generally, less-intensive outside support and intervention are needed for individuals with more change-predisposing attributes than for those with fewer such attributes48,49 (Table 3). Scarce resources can be focused on strengthening an individual's factors favoring change and targeting the most intensive support to people with the fewest pre-disposing attributes. Theoretical perspectives also make clear the complementary role played by policies and practices in settings outside health care in promoting healthy behaviors across society.

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The Clinician-Patient Relationship

As our understanding of behavioral counseling interventions has become more sophisticated, interventions have evolved beyond the limits of one-on-one interactions between a clinician and a patient. However, the use of additional resources within and outside the primary care setting to support the clinician by no means undermines the importance of the clinician-patient relationship in promoting behavior change. Effective clinician communication is important for a variety of patient outcomes.50,51 Clinician advice to change lifestyle habits is associated with increased efforts to change52,53 and is effective in encouraging smoking cessation,11,12,14,15 reducing problem drinking,11,16 and modifying some activity- and diet-associated cardiovascular risk factors.11,20 Clinician advice is also associated with increased satisfaction with medical care.30,54,55 Such advice has been suggested to "prime" patients, especially women, to attend to and act on subsequent educational information.56 In a recent cross-sectional study among members of a managed care organization,57 receipt of professional advice to change was associated with a higher readiness to change smoking, physical activity, and diet behaviors. Preliminary data also suggest that advice from one's health care provider based on personal health status is a very strong external cue to health-promoting action.58

The clinician employing an empathetic "partnership" approach avoids engendering resistance to behavior change advice.59 Such an approach emphasizes the patient's role in interpreting advice and explores, rather than prescribes, how best to proceed. According to a Toronto consensus conference on doctor-patient communication,60 "effective communication between doctor and patient is a central function that cannot be delegated."

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The Potential Impact of Health Behavior-Change Programs in Clinical Care

Appreciating behavioral counseling interventions requires a true population-based medicine perspective (i.e., intervening with individuals, but recognizing that the health benefits may not be as clinically visible individually as they are clinically meaningful when considered for the whole). Individually, brief behavioral counseling interventions that are feasible in health care settings often have only modest behavior change impacts. For example, only 5 percent to 15 percent of those receiving an intervention make clinically significant changes, such as quitting smoking12 or reducing heavy drinking.11 Even at a population level, overall risk factors typically change only 1 percent to 20 percent.16,17,19,20,22,61 However, these "modest" impacts translate to significant benefits to the health of the population (and to multiple individuals) when systematically applied to a large proportion of those in need.48,62-65 This opportunity for substantial public health benefit comes about only when behavior change interventions are applied broadly to entire populations of patients. Given this, population-based behavioral interventions generally offer a range of intervention options including motivational strategies designed for people not ready to change.64

Impact of Health Behavior Change Programs

Highly efficacious, intensive group tobacco cessation approaches12,48,64,66 have typically been perceived as producing higher quit rates than primary care behavioral counseling interventions. Group approaches produce quit rates of 30 percent to 40 percent but reach only a small proportion of highly motivated smokers volunteering for treatment (roughly 3 percent to 5 percent of all smokers). Thus, their potential impact on the prevalence of smoking (Impact = Participation Rate x Efficacy) is substantially less than systematically delivered primary care interventions, which can feasibly reach the 70 percent of smokers who visit their clinicians each year and result in 5 percent to 10 percent overall quit rates.

Applying a similar public health approach, modest effective clinical interventions addressing problem drinking21,22,62 and dietary change61 are projected to have significant population impact when broadly delivered.

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Practical Approaches to Overcome Barriers to Behavioral and Counseling Interventions

Numerous barriers to preventive service delivery continue to exist in present-day health care settings, most of which are still organized mainly around symptom-driven, acute illness care.67,68 These barriers include:

Further, feedback to clinicians about results of preventive care is largely non-existent or can even be negative.69 For example, clinicians or their staffs may never "hear" about the patients who followed through on a referral or made positive lifestyle changes, but may encounter complaints about repeated advice to quit smoking, even when voiced by only a few.

Unfortunately, most of these challenges are exacerbated for health behavior-change interventions. Thus, risk assessment and behavioral counseling interventions are delivered even less frequently than screenings.8 Moreover, although clinicians increasingly agree that most health-promoting behaviors are important to patients' health,32 they report skepticism about patients' willingness to change these behaviors and about their own ability to intervene successfully in these areas.70,71 Clinicians often lack the knowledge, skills, and support systems to quickly and easily provide a range of different behavioral counseling interventions, particularly in the limited time available.69,72,73 These barriers provide an important rationale for proposing a consistent overall approach (such as the Five A's) for describing behavioral counseling interventions across the range of topics in clinical care.

Evaluations of continuing medical education efforts show that programs based on the principles of adult learning that build clinician skills using interactive, sequential learning opportunities in settings such as workshops, small groups, and individual training sessions appear to have the greatest influence on clinician practices and patient outcomes.74 Even relatively brief physician training along these lines (2 to 3 hours) can improve the delivery of clinical preventive services.75,76

However, clinician training may be efficacious only in the presence of an office-support program that assists clinicians in carrying out behavioral counseling interventions and incorporating them into routine care.77,78 As Solberg et al79 noted, "Without such systems, delivery of preventive services must depend on the memory, motivation, and time of individual clinicians." Fortunately, we also have a better understanding of the organized office or health-plan processes that support the systematic and consistent delivery of clinical preventive services. These systems typically consist of:

  1. Preventive services guidelines.
  2. Basic support processes that identify and activate those who need a service, summarize needed services on the patient chart, and remind the clinician during a visit.
  3. Prevention resources to provide in-clinic and after-clinic counseling, support, and followup.80

A recent randomized controlled trial81 reported that, compared with control practices, community family practices demonstrated significantly increased clinical preventive services delivery 1 year after receiving practice-tailored systems support for preventive service delivery. Delivery of behavioral counseling interventions was particularly improved. The Put Prevention Into Practice (PPIP) program, sponsored by AHRQ, has a variety of materials to help make these services an integral part of primary care. PPIP has developed tools to assist clinicians in determining which clinical preventive services patients should receive, and it produces guides and materials for service delivery in a variety of settings.82 PPIP also provides resources for patients to guide health maintenance decisions and to keep track of their preventive care.

Ongoing innovations in the design and delivery of behavioral counseling interventions can also address barriers, improve patient access, and increase treatment effectiveness. Clinicians' efforts are enhanced when the entire health care team takes appropriate and complementary roles in delivering efficacious interventions.29,83,84 For example, health educators and nurse case managers who contact and support smokers between visits85 extend intervention opportunities beyond the initial primary care visit. Coordination with resources outside the clinical setting, such as programs and services through voluntary agencies and other community resources, can help patients conveniently access needed supports after they leave the visit.67 This integration may increase health care system efficiency and impact by creating congruence between clinical interventions and the broader community.86

Expanding communication technologies allow both passive and interactive use25 of telephones, videos, CD-ROMs, the Internet, and other computer-assisted venues to enhance and personalize behavioral intervention content28,87 and to prolong contact with the patient, while reducing the services that must be directly provided by clinical staff.67 Such computer-based print, telephone, and video communications have boosted treatment outcomes over standard "one-size-fits-all" interventions in several behavioral areas (e.g., smoking cessation and diet modification), with greatest benefits sometimes seen in low-income populations.88-90 Although some of these technologies are relatively new and still under evaluation, advances in information and communication technologies hold great promise for enhancing intervention efficiency by automating assessment, education, and patient contacts, especially for ongoing followup and support. Taken together, these ongoing innovations offer opportunities to address key barriers to behavioral counseling interventions in clinical settings.

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